Measuring What Matters: How Cognitive Testing Transformed Narcolepsy Clinical Trials

By Helen Brooker

Narcolepsy research has evolved from a narrow focus on sleepiness to a broader recognition of the disorder’s cognitive impact, reshaping how treatments are developed and evaluated. Early tools like polysomnography and the Multiple Sleep Latency Test (MSLT) provided objective measures of excessive daytime sleepiness but overlooked patients’ reports of persistent deficits in attention, memory, and executive function. As new therapies emerged, particularly wake-promoting agents, the limitations of traditional measures became clear—regulators and clinicians needed evidence of improvements beyond sleep propensity.

Computerized cognitive assessments, particularly the Cognitive Drug Research (CDR) System, filled this critical gap. Studies incorporating the CDR System demonstrated that treatments like armodafinil produced significant cognitive and functional improvements independent of sleepiness measures, evidence that proved pivotal for regulatory approval and market positioning. This full article delves into how, with decades of validation and regulatory acceptance, the CDR System provides a proven foundation for comprehensive assessment. This system ensures that clinical development addresses the outcomes most meaningful to patients.